Hepatic AngiosarcomaNCT03025438
Cytological Diagnosis of Hepatic Angiosarcoma and Its Histopathologic Correlation
An observational study of Hepatic Angiosarcoma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Cytological diagnosis of hepatic angiosarcoma by fine-needle aspiration (FNA) or imprint cytology is difficult due not only to its various cytomorphologic features but also clinical rarity. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Hepatic Angiosarcoma
- How many people
- 13 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Jan 2017to 3 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients of a medical center in Taiwan; National Taiwan University Hospital (NTUH)
Who may be able to join
- Consecutive patients of hepatic angiosarcoma performed FNA and/or imprint cytological examinations in our hospital.
Who cannot join
- Patients without pathological confirmation.
- Patients who are not angiosarcoma by pathological reviews.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital, Department of laboratory medicine
Taipei, 10008
About this study
Cytological diagnosis of hepatic angiosarcoma by fine-needle aspiration (FNA) or imprint cytology is difficult due not only to its various cytomorphologic features but also clinical rarity. Vasoformative features, such as pseudo-acini, branching pseudo-capillary structure, and intracytoplasmic lumina, are clues to achieve the diagnosis. But these features are not always present. In order to find clues for cytological diagnosis of angiosarcoma, we collected cases of hepatic angiosarcoma to study their cytological features. And then compared these features with those in their histopathological biopsy or resection.
Read the detailed description
Hepatic angiosarcoma is a rare hepatic malignant tumor. Although diagnosis of hepatic angiosarcoma by FNA cytology has been reported since 1982, followed by several studies, its cytomorphologic features were still not well recognized by cytopathologists because of its clinical rarity and various morphologic features.
We reviewed literatures about cytomorphology of hepatic angiosarcoma by FNA. There are only 11 cases retrieved in 10 articles searched from Medline. The sex M/F ratio was 6/4 (one unknown); age range was 56 to 79 years old. In initial cytological evaluation, four cases got angiosarcoma or consistent/suspicious angiosarcoma diagnosis. Positive for malignancy, sarcoma, and poorly differentiated spindle cell lesion were in one case respectively. One was diagnosed as atypical cells. Remaining three were unavailable by their reports.
In cytological morphologic features, all but one met least 2 of 3 cytological cellular criteria of angiosarcoma cells: spindle cells, epithelioid cells, and pleomorphic cells. In cytological architectural features, 7 of 11 cases showed vasoformative structures; 5 of 11 cases showed intracytoplasmic lumen or erythrophagocytosis. Ten of 11 cases had histologic/pathologic confirmation as angiosarcoma. One case reported interrelation of tumor structures and their own accompanied liver tissue in cell blocks.
- Conditions
- Hepatic Angiosarcoma
- Keywords
- angiosarcoma, Cytology, liver, cancer
- Medical subject headings
- Hemangiosarcoma, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: about 10 years from the date of diagnosis to the last follow-up date by medical record
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study start17 Jan 2017
- Primary completion4 Feb 2017
- Study completion3 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic AngiosarcomaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wern-Cherng Cheng, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025438
- Sponsor's protocol ID
- 201603013RINA
- Status last verified
- Jan 2017
- First submitted
- 16 Jan 2017
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytological Diagnosis of Hepatic Angiosarcoma and Its Histopathologic Correlation
- ClinicalTrials.gov ID
- NCT03025438
- Acronym / sponsor ID
- 201603013RINA
- Conditions
- Hepatic Angiosarcoma
- Keywords
- angiosarcoma, Cytology, liver, cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 4 Feb 2017 (actual)
- Study completion
- 3 Apr 2017 (actual)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cytological diagnosis of hepatic angiosarcoma by fine-needle aspiration (FNA) or imprint cytology is difficult due not only to its various cytomorphologic features but also clinical rarity. Vasoformative features, such as pseudo-acini, branching pseudo-capillary structure, and intracytoplasmic lumina, are clues to achieve the diagnosis. But these features are not always present. In order to find clues for cytological diagnosis of angiosarcoma, we collected cases of hepatic angiosarcoma to study their cytological features. And then compared these features with those in their histopathological biopsy or resection.
Detailed description
Hepatic angiosarcoma is a rare hepatic malignant tumor. Although diagnosis of hepatic angiosarcoma by FNA cytology has been reported since 1982, followed by several studies, its cytomorphologic features were still not well recognized by cytopathologists because of its clinical rarity and various morphologic features.
We reviewed literatures about cytomorphology of hepatic angiosarcoma by FNA. There are only 11 cases retrieved in 10 articles searched from Medline. The sex M/F ratio was 6/4 (one unknown); age range was 56 to 79 years old. In initial cytological evaluation, four cases got angiosarcoma or consistent/suspicious angiosarcoma diagnosis. Positive for malignancy, sarcoma, and poorly differentiated spindle cell lesion were in one case respectively. One was diagnosed as atypical cells. Remaining three were unavailable by their reports.
In cytological morphologic features, all but one met least 2 of 3 cytological cellular criteria of angiosarcoma cells: spindle cells, epithelioid cells, and pleomorphic cells. In cytological architectural features, 7 of 11 cases showed vasoformative structures; 5 of 11 cases showed intracytoplasmic lumen or erythrophagocytosis. Ten of 11 cases had histologic/pathologic confirmation as angiosarcoma. One case reported interrelation of tumor structures and their own accompanied liver tissue in cell blocks.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients of a medical center in Taiwan; National Taiwan University Hospital (NTUH)
Key inclusion criteria (1 listed)
- Consecutive patients of hepatic angiosarcoma performed FNA and/or imprint cytological examinations in our hospital.
Key exclusion criteria (2 listed)
- Patients without pathological confirmation.
- Patients who are not angiosarcoma by pathological reviews.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
all cause mortality
Time frame: about 10 years from the date of diagnosis to the last follow-up date by medical record
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Individual participant dataSharing planned: Undecided
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A French Multicenter Observational Retrospective Study of Rare Primary Liver Cancers
Hepatocholangiocarcinoma, Fibrolamellar Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wern-Cherng Cheng, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Angiosarcoma, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: about 10 years from the date of diagnosis to the last follow-up date by medical record). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.